Colonization with MRSA, VRE and ESBL [ Time Frame: On admission ] [ Designated as safety issue: No ]

By taking surveillance swabs from nose, perineum and wounds (if present) on admission we will assess whether patients are colonized with MRSA, VRE and ESBL at the moment of ICU admission. Swabs will be processed on chromogenic agars.

Colonization with MRSA, VRE and ESBL [ Time Frame: During ICU stay ] [ Designated as safety issue: No ]

By taking surveillance swabs twice weekly from nose, perineum and wounds (if present) we will assess whether patients become colonized with MRSA, VRE and ESBL during ICU stay. Swabs will be processed on chromogenic agars.

Note: for patients admitted for longer than 21 days, surveillance is reduced to once weekly.

In phase 2, we implement a hygiene improvement program. We will assess if this program reduces the number of patients acquiring colonization with MRSA, VRE and ESBL. We will measure colonization as stated in the primary outcome measure.

In phase 3, we will implement direct feedback of screening results, and isolation of colonized patients. Swabs will be processed either by chromogenic agar (a) or molecular tests (b). Thus, the effect of these interventions on incidence density of new acquisitions of MRSA, VRE or ESBL will be assessed.

We will collect data on all bacteremias occuring during ICU stay, after completion of the trial. We include all bacteremias with s aureus (MSSA and MRSA), e faecium/ e faecalis ("S" and "R") and enterobacteriaceae ("S" and "R"). Data will be collected from the microbiology labs.

In this trial, colonization of patients with these AMRB will be assessed in the baseline period (6m). In phase 2 the effect of a Hygiene Improvement Program, including Chlorhexidine body washings and a Hand Hygiene training program, will be assessed (6m). In phase 3 units will be randomized to either Active Surveillance with Chromagar based tests or a Molecular based tests.

A cluster-randomized trial with a stepped wedge design will be conducted in adult ICU's throughout Europe

The MOSAR-ICU trial is motivated by three primary considerations:

Advances in behavioral sciences and research about (hand) hygiene compliance have allowed a better understanding of barriers to increase compliance with (hand) hygiene practices within healthcare institutions;

Recent investigations have identified new rapid tests, both chromogenic media and molecular based tests, which may help identifying previously unknown carriage of AMRB at the time of admission; and

Currently practiced procedures, such as regular surveillance of all patients and daily cleansing of ICU patients with Chlorhexidine, have not been evaluated properly for their effectiveness.

In conclusion, evidence base derived recommendations from prospective studies regarding the costeffectiveness of different control strategies are lacking.

This study assess the impact of the three interventions on ICU acquired colonisation rates for AMRB(MRSA,VRE and ESBL).

Study design: Multi-center, cluster-randomised clinical trial.

Study population: Adult patients admitted to the ICU.

Intervention: The first phase of the study will be a 6-month baseline period to determine acquisition rates of AMRB during current standard practice in the individual participating centers (including currently performed surveillance strategies). The second phase will consist of a Hygiene Improvement Program to improve standard precautions and hand hygiene; and daily washing of all ICU patients with Chlorhexidine gluconate (HIP; 6 months). In both periods Contact Precautions (contact isolation) will be implemented for carriers of AMRB, as identified upon clinical cultures and following current practice of individual wards. In the third phase of the study (12 months) units will be randomized, and all interventions of phase 2 will be continued in all units. Half of the units will implement surveillance (admission and twice weekly cultures) of all admitted patients for carriage of MRSA and VRE using chromogenic agar. The other half will add molecular based rapid testing of ALL admission cultures for MRSA and VRE in addition to twice weekly screening of all patients with Chromagar based tests for MRSA, VRE and ESBL.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

14318

Completion Date

May 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

colonization with either MRSA, VRE or ESBL is endemic

at least one dedicated infection control physician

ability to obtain, store and analyze surveillance cultures

at least 8 ICU beds; all of which have possibility for mechanical ventilation

ability to collect the data required for analysis

written approval of the institution's IRB

signed protocol signature page

Exclusion Criteria:

burn units

cardiothoracic units

pediatric and neonatal ICUs

ICU is currently using rapid diagnostic testing in their screening program for AMRB

ICU is planning to enroll subjects in studies testing investigational agents for the purpose of eradicating or preventing colonization with MRSA, VRE or ESBL or devices or practice management strategies that have colonization and/or infection with AMRB as an outcome

using SOD/ SDD or any topical antimicrobial therapy

using chlorhexidine body washings

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects